David W Johnson1, Sunil V Badve2, Elaine M Pascoe3, Elaine Beller4, Alan Cass5, Carolyn Clark6, Janak de Zoysa7, Nicole M Isbel2, Steven McTaggart8, Alicia T Morrish3, E Geoffrey Playford9, Anish Scaria3, Paul Snelling10, Liza A Vergara3, Carmel M Hawley2. 1. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia; Translational Research Institute, Brisbane, QLD, Australia. Electronic address: david_johnson@health.qld.gov.au. 2. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia. 3. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia. 4. Centre for Research in Evidence-Based Practice, Bond University, Gold Coast, QLD, Australia. 5. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Menzies School of Health Research, Darwin, NT, Australia. 6. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Nambour Hospital, Nambour, QLD, Australia. 7. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Renal Medicine, North Shore Hospital, Auckland, New Zealand. 8. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Child and Adolescent Renal Service, Royal Children's and Mater Children's Hospitals, Brisbane, QLD, Australia. 9. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Infection Management Services, Princess Alexandra Hospital, Brisbane, QLD, Australia. 10. Australasian Kidney Trials Network, University of Queensland, Brisbane, QLD, Australia; Department of Nephrology, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
Abstract
BACKGROUND: There is a paucity of evidence to guide the best strategy for prevention of peritoneal-dialysis-related infections. Antibacterial honey has shown promise as a novel, cheap, effective, topical prophylactic agent without inducing microbial resistance. We therefore assessed whether daily application of honey at the exit site would increase the time to peritoneal-dialysis-related infections compared with standard exit-site care plus intranasal mupirocin prophylaxis for nasal carriers of Staphylococcus aureus. METHODS: In this open-label trial undertaken in 26 centres in Australia and New Zealand, participants undergoing peritoneal dialysis were randomly assigned in a 1:1 ratio with an adaptive allocation algorithm to daily topical exit-site application of antibacterial honey plus standard exit-site care or intranasal mupirocin prophylaxis (only in carriers of nasal S aureus) plus standard exit-site care (control group). The primary endpoint was time to first infection related to peritoneal dialysis (exit-site infection, tunnel infection, or peritonitis). The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12607000537459. FINDINGS: Of 371 participants, 186 were assigned to the honey group and 185 to the control group. The median peritoneal-dialysis-related infection-free survival times were not significantly different in the honey (16·0 months [IQR not estimable]) and control groups (17·7 months [not estimable]; unadjusted hazard ratio 1·12, 95% CI 0·83-1·51; p=0·47). In the subgroup analyses, honey increased the risks of both the primary endpoint (1·85, 1·05-3·24; p=0·03) and peritonitis (2·25, 1·16-4·36) in participants with diabetes. The incidences of serious adverse events (298 vs 327, respectively; p=0·1) and deaths (14 vs 18, respectively; p=0·9) were not significantly different in the honey and control groups. 11 (6%) participants in the honey group had local skin reactions. INTERPRETATION: The findings of this trial show that honey cannot be recommended routinely for the prevention of peritoneal-dialysis-related infections. FUNDING: Baxter Healthcare, Queensland Government, Comvita, and Gambro.
RCT Entities:
BACKGROUND: There is a paucity of evidence to guide the best strategy for prevention of peritoneal-dialysis-related infections. Antibacterial honey has shown promise as a novel, cheap, effective, topical prophylactic agent without inducing microbial resistance. We therefore assessed whether daily application of honey at the exit site would increase the time to peritoneal-dialysis-related infections compared with standard exit-site care plus intranasal mupirocin prophylaxis for nasal carriers of Staphylococcus aureus. METHODS: In this open-label trial undertaken in 26 centres in Australia and New Zealand, participants undergoing peritoneal dialysis were randomly assigned in a 1:1 ratio with an adaptive allocation algorithm to daily topical exit-site application of antibacterial honey plus standard exit-site care or intranasal mupirocin prophylaxis (only in carriers of nasal S aureus) plus standard exit-site care (control group). The primary endpoint was time to first infection related to peritoneal dialysis (exit-site infection, tunnel infection, or peritonitis). The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12607000537459. FINDINGS: Of 371 participants, 186 were assigned to the honey group and 185 to the control group. The median peritoneal-dialysis-related infection-free survival times were not significantly different in the honey (16·0 months [IQR not estimable]) and control groups (17·7 months [not estimable]; unadjusted hazard ratio 1·12, 95% CI 0·83-1·51; p=0·47). In the subgroup analyses, honey increased the risks of both the primary endpoint (1·85, 1·05-3·24; p=0·03) and peritonitis (2·25, 1·16-4·36) in participants with diabetes. The incidences of serious adverse events (298 vs 327, respectively; p=0·1) and deaths (14 vs 18, respectively; p=0·9) were not significantly different in the honey and control groups. 11 (6%) participants in the honey group had local skin reactions. INTERPRETATION: The findings of this trial show that honey cannot be recommended routinely for the prevention of peritoneal-dialysis-related infections. FUNDING: Baxter Healthcare, Queensland Government, Comvita, and Gambro.
Authors: Lei Zhang; Sunil V Badve; Elaine M Pascoe; Elaine Beller; Alan Cass; Carolyn Clark; Janak de Zoysa; Nicole M Isbel; Steven McTaggart; Alicia T Morrish; E Geoffrey Playford; Anish Scaria; Paul Snelling; Liza A Vergara; Carmel M Hawley; David W Johnson Journal: Perit Dial Int Date: 2015-07-29 Impact factor: 1.756